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NCT00025506 · ADVERSE EVENTS

Adverse events

Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus · Source last updated 2019-07-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Thalidomide

Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.

15 / 4545 / 45Not reported / Not reported

Group identifiers: EG000: Thalidomide

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
    term
    Thrombosis Embolism
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      45
    term
    Constitutional Symptoms Other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    term
    Dehydration
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
    term
    Nausea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    term
    Gi Other
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    term
    Hemorrhage With Grade 3/4 Thrombocytopenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    term
    Bilirubin
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      45
    term
    Dyspnea

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    term
    Inner Ear/Hearing
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      45
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      45
    term
    Leukopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      45
    term
    Transfusion Prbc's
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      45
    term
    Anemia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    term
    Transfusion Platelets
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    term
    Arrhythmia Nodal/Junctional Dysrhythmia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      45
    term
    Edema
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
    term
    Thrombosis Embolism
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    term
    Palpitations
Complete source fields
event Groups
  1. description
    Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
    id
    EG000
    other Num Affected
    45
    other Num At Risk
    45
    serious Num Affected
    15
    serious Num At Risk
    45
    title
    Thalidomide
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    term
    Inner Ear/Hearing
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      45
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      45
    term
    Leukopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      45
    term
    Transfusion Prbc's
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      45
    term
    Anemia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    term
    Transfusion Platelets
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    term
    Arrhythmia Nodal/Junctional Dysrhythmia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      45
    term
    Edema
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
    term
    Thrombosis Embolism
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    term
    Palpitations
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
    term
    Thrombosis Embolism
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      45
    term
    Constitutional Symptoms Other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    term
    Dehydration
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
    term
    Nausea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    term
    Gi Other
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    term
    Hemorrhage With Grade 3/4 Thrombocytopenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    term
    Bilirubin
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      45
    term
    Dyspnea
time Frame
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.

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